PDUFA Fees Push Higher In FY 2024, While Biosimilar Fees Race Downward
Fiscal year 2024 prescription drug user fees skyrocket in part because of a low application volume in FY 2022, while biosimilar user fees continue to drop due to the program’s healthy operating reserve.
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After years where many more applications received priority assessments than standard assessments, in FY 2022 the difference narrowed.
However, user fee carryover balances will not last forever and service cuts are inevitable if a shutdown lingers for several weeks.
The cost of filing a New Drug Application with the US FDA has pushed above the $4 million mark. That is a remarkable rate of increase from the original $100,000 fee set in 1992 – but it does buy a lot more.